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US FDA finds quality control problems at Sun Pharma's Halol plant

The violations listed by the FDA after its latest inspection at Halol include problems with Sun's quality control system

Reuters  |  Mumbai 

The US Food and Drug Administration (FDA) has raised concerns about the quality control process at Indian drugmaker Sun Pharmaceutical Industries' Halol factory, an inspection report obtained by Reuters shows. Earlier this month, Sun said it had been informed by the US health regulator of more concerns about its plant in the western Indian state of Gujarat after a recent inspection, but details of the violations were unclear at the time. According to the 14-page-long report, a copy of which was obtained by Reuters through a Freedom of Information Act Request, FDA has ...

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First Published: Tue, December 13 2016. 17:50 IST
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